HEP® Tele-Rehabilitation for Preterm Infants at Developmental Risk: A Feasibility Study (HEP®-Preterm)
2026年7月21日 更新者：Izgi Miray Demirbag
Feasibility Study of HEP® (Homeostasis-Enrichment-Plasticity) Tele-Rehabilitation for Preterm Infants at Developmental Risk
Several early intervention approaches based on sensory and motor environmental enrichment have demonstrated neurobehavioral benefits and improvements in motor and cognitive skills in infants.
Tele-rehabilitation has also been shown to positively impact the motor and cognitive development of at-risk infants.
However, limited research has examined the effects of environmental enrichment-based early interventions delivered via tele-rehabilitation on sensory, motor, cognitive, language, and socio-emotional skills, adaptive behaviors, parental goals, and parental anxiety in preterm infants at developmental risk, as well as the feasibility of delivering such interventions online.
The proposed study aims to evaluate the effects of the environmental enrichment-based HEP® approach delivered through tele-rehabilitation on these developmental outcomes in preterm infants, thereby contributing to the existing literature.
研究概览
详细说明
In our study, 16 infants meeting the inclusion criteria received a tele-rehabilitation intervention based on the environmental enrichment-oriented HEP® approach. This was a single-group feasibility study, with no separate control group. The infants were re-evaluated using the same assessment methods before and after the intervention.
The initial and final assessments took place entirely online, and the assessor was different from the person delivering the intervention. The intervention lasted 12 weeks and was conducted entirely online, with 45-minute sessions delivered according to environmental enrichment principles. Parent training was also provided to support the implementation of the intervention at home.
Infants' demographic, perinatal, natal, and postnatal information was collected via a "Demographic Information Form" prepared by the researcher. Motor capacities were evaluated using the Infant Motor Profile (IMP) and the Alberta Infant Motor Scale (AIMS). Parents' depression, anxiety, and stress levels were measured with the Depression Anxiety Stress Scale (DASS-21). Additionally, parents completed the Ages & Stages Questionnaires (ASQ) to assess their child's gross motor, fine motor, problem-solving, communication, and personal-social development; the Ages & Stages Questionnaires®: Social-Emotional (ASQ:SE®) to evaluate socio-emotional and behavioral difficulties; and the Young Children's Participation and Environment Measure (YC-PEM) to evaluate their child's participation in various activities. Individualized goals for each infant were established at the beginning of the intervention using the Goal Attainment Scale (GAS). At the end of the intervention, parents also completed the Social Validity Form developed by the researcher.
All assessments and the intervention were conducted online.
研究类型
介入性
注册 (实际的)
16
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
Beykoz
-
Istanbul、Beykoz、土耳其（türkiye）、34810
- Sense On
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 孩子
接受健康志愿者
不
描述
Inclusion Criteria:
- Infants with a corrected age between 4 and 12 months.
- Infants born at or before 36 weeks and 6 days of gestation.
- Infants with no congenital anomalies.
- Families who agree to participate regularly in the study process.
Exclusion Criteria:
- Infants with major visual or hearing impairments.
- Infants with any genetic syndrome or congenital anomalies.
- Infants with medical conditions that prevent active participation in the study (e.g., oxygen dependence).
- Infants participating in other experimental rehabilitation studies.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：HEP® Tele-Rehabilitation Intervention
This arm includes infants receiving the HEP® (Homeostasis-Environmental Enrichment-Plasticity) approach, an early intervention program delivered entirely online through tele-rehabilitation.
The intervention is conducted in 45-minute sessions over 12 weeks, following environmental enrichment principles.
Parent training is provided to support the implementation of activities at home, and individualized developmental goals are established for each infant at the beginning of the intervention.
All assessments and the intervention are conducted online.
|
This group receives the HEP® Tele-Rehabilitation Intervention, an early intervention program based on the Homeostasis-Environmental Enrichment-Plasticity approach and delivered entirely through tele-rehabilitation.
The intervention consists of 45-minute online sessions conducted weekly over 12 weeks and follows environmental enrichment principles.
Parent training is provided to support the implementation of activities in the home environment, and individualized developmental goals are established for each infant at the beginning of the intervention.
All assessments and intervention procedures are conducted remotely via online platforms.
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
The Alberta Infant Motor Scale (AIMS)
大体时间：At baseline and immediately after the 12-week intervention.
|
The Alberta Infant Motor Scale (AIMS) is a standardized assessment designed to evaluate motor development in infants.
It specifically measures both fine and gross motor skills across a range of developmental stages.
This assessment provides valuable information regarding infants' physical abilities and developmental progress.
The test typically takes approximately 15 minutes to administer, and scores are interpreted by comparison with a normative database.
|
At baseline and immediately after the 12-week intervention.
|
|
The Ages and Stages Questionnaires (ASQ)
大体时间：At baseline and immediately after the 12-week intervention.
|
The ASQ is a developmental screening tool that enables parents to assess an infant's developmental progress.
The questionnaire comprises three sections: demographic information, a 30-item developmental section, and seven open-ended questions.
The 30-item section evaluates five developmental domains-communication, fine motor skills, gross motor skills, problem-solving, and personal-social development-each domain consisting of six questions.
|
At baseline and immediately after the 12-week intervention.
|
|
Depression Anxiety Stress Scales-21 (DASS-21)
大体时间：At baseline and immediately after the 12-week intervention.
|
The DASS-21 is a validated and reliable tool for screening depressive and anxiety disorders, and it effectively assesses the severity of three psychological states through 21 items.
The scale consists of three subscales: depression (7 items), anxiety (7 items), and stress (7 items).
Each item is rated on a 4-point Likert scale ranging from 0 (Did not apply to me at all) to 3 (Applied to me very much or most of the time).
Lower scores on the subscales indicate better psychological well-being.
|
At baseline and immediately after the 12-week intervention.
|
|
Young Children's Participation and Environment Measure (YC-PEM)
大体时间：At baseline and immediately after the 12-week intervention.
|
The YC-PEM is a parent-completed measure designed to assess the level and quality of participation of children aged 0-5 years in various activities and the environments in which these activities take place.
|
At baseline and immediately after the 12-week intervention.
|
|
The Goal Attainment Scale (GAS)
大体时间：At baseline and immediately after the 12-week intervention.
|
The Goal Attainment Scale (GAS) is the most commonly recommended goal-setting methodology for measuring change during and after intervention in clinical and research applications.
The GAS, which assesses the child's achievement of individual goals established with parents at the beginning of the intervention, is a reliable tool for children with developmental challenges and provides subjective information about the child's needs.
The GAS has a rating scale of "-2" to "+2."
|
At baseline and immediately after the 12-week intervention.
|
|
The Infant Motor Profile (IMP)
大体时间：At baseline and immediately after the 12-week intervention.
|
The IMP is a method designed to evaluate the motor behaviour of infants aged 3 to 18 months CA.
The IMP is based on a video recording of a semi-standardized play session of about 15 minutes, during which an assessor plays with the infant in such a way that the IMP items can be assessed.
This means that the playing assessor has knowledge of the IMP items, allowing her to adapt the assessment to the infant's functional abilities and the IMP needs.
The 80 items of the IMP evaluate motor behaviour in supine and prone positions; while sitting, standing, and walking; when reaching and grasping; and during manipulation.
It is a discriminative, evaluative, and predictive measurement.
The IMP has been developed for health care professionals working in the feld of early detection of developmental disorders and early intervention.
|
At baseline and immediately after the 12-week intervention.
|
|
Ages and Stages Questionnaires: Social-Emotional (ASQ:SE)
大体时间：At baseline and immediately after the 12-week intervention.
|
The ASQ:SE was developed as a complementary tool to the ASQ to assess social-emotional development and behavioral difficulties in infants.
The questionnaire is completed by parents and evaluates key domains, including self-regulation, adaptability, communication, adaptive behavior, autonomy, emotional status, and interactions with
|
At baseline and immediately after the 12-week intervention.
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 研究主任：Aymen Balıkcı, Dr. Physiotherapist
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2024年11月1日
初级完成 (实际的)
2025年3月1日
研究完成 (实际的)
2025年3月1日
研究注册日期
首次提交
2025年11月13日
首先提交符合 QC 标准的
2026年7月21日
首次发布 (实际的)
2026年7月27日
研究记录更新
最后更新发布 (实际的)
2026年7月27日
上次提交的符合 QC 标准的更新
2026年7月21日
最后验证
2026年7月1日
更多信息
与本研究相关的术语
关键字
其他研究编号
- E-10840098-202.3.02-736
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
IPD 计划说明
Participant consent does not include sharing data with other researchers.
Data will be maintained in strict confidentiality.
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.